A Randomized Controlled Trial of Mandatory Naps for Physicians in Training

Fatigue Clinical Trial

Official title:

Interventions to Improve Fatigue Management Among Physician Trainees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874510
• Other study ID #: EDU 08-429
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2009
• Last updated: January 22, 2016
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will consist of a randomized controlled trial in which the investigators test the feasibility and effectiveness of mandatory nap programs for physicians in training. One site will be the general medical service of the Philadelphia Veterans Affairs Medical Center. The other will be the oncology service of the Hospital of the University of Pennsylvania. The primary outcome will be the amount slept while on call. The first year will test the efficacy of a 5 hour mandatory nap schedule, the second year will test the efficacy of a 3 hour mandatory nap schedule.

Description:

Background: The release of the Institute of Medicine report on resident work hours and patient safety highlighted the risks to patient and resident safety of extended duty on-call shifts.

Objectives: The purpose of this study is to test the feasibility and effectiveness of mandatory naps during extended duty overnight shifts for residents.

Methods: For each site (PVAMC and HUP), every other month residents will be randomized to either work the standard schedule (which involves interns being on duty for 30 continuous hours) vs. the mandatory nap schedule, which involves interns signing out their beepers for 5 hours in the middle of the night to covering night floats and for 3 hours in Year 2. The primary outcome will be the amount slept as measured by actigraphs, with secondary outcomes of cognitive alertness measured by 3-minute psychomotor vigilance testing (PVT), Stanford sleepiness Scale, and other measures of resident and patient well-being.

Status: Recruitment complete, analyses phase only

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: December 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Residents in the University of Pennsylvania Internal Medicine Training Program who are rotating through either Philadelphia VA Medical Center Medical Service or Hospital of University of Pennsylvania Oncology Service

Exclusion Criteria:

• Refusal to consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fatigue

Intervention

Behavioral:
• Mandatory Naps
As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am

Locations

Country	Name	City	State
United States	VA Medical Center, Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (3)

Halpern SD, Kohn R, Dornbrand-Lo A, Metkus T, Asch DA, Volpp KG. Lottery-based versus fixed incentives to increase clinicians' response to surveys. Health Serv Res. 2011 Oct;46(5):1663-74. doi: 10.1111/j.1475-6773.2011.01264.x. Epub 2011 Apr 14. — View Citation

Shea JA, Dinges DF, Small DS, Basner M, Zhu J, Norton L, Ecker AJ, Novak C, Bellini LM, Dine CJ, Mollicone DJ, Volpp KG. A randomized trial of a three-hour protected nap period in a medicine training program: sleep, alertness, and patient outcomes. Acad M — View Citation

Volpp KG, Shea JA, Small DS, Basner M, Zhu J, Norton L, Ecker A, Novak C, Bellini LM, Dine CJ, Mollicone DJ, Dinges DF. Effect of a protected sleep period on hours slept during extended overnight in-hospital duty hours among medical interns: a randomized — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours Slept on Overnight Extended Duty Call Shifts	Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.	12 months	No